K-number	K151025
Device name	iHearTest
Applicant	Ihear Medical, Inc.
Product code	EWO
Device class	Class II
Decision date	Dec 29, 2015
Decision	Substantially Equivalent
Regulation	874.1050

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Source

View the full FDA submission: accessdata.fda.gov

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iHearTest

Everything you need for a 510(k) submission. Nothing you don't.